[Federal Register Volume 76, Number 242 (Friday, December 16, 2011)]
[Proposed Rules]
[Pages 78216-78224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-32204]



[[Page 78216]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 121

RIN 0906-AA73


Organ Procurement and Transplantation Network

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: This notice of proposed rulemaking sets forth the Secretary's 
proposal to include vascularized composite allografts, described below, 
within the definition of organs covered by the rules governing the 
operation of the Organ Procurement and Transplantation Network. The 
Secretary further proposes a corresponding change to the definition of 
human organs covered by section 301 of the National Organ Transplant 
Act of 1984, as amended.

DATES: To be considered, comments on this proposed rule must be 
submitted by February 14, 2012. Subject to consideration of the 
comments submitted, the Department intends to publish final 
regulations.

ADDRESSES: You may submit comments, identified by RIN 0906-AA73, by any 
of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: http://www.hrsa.gov/. Follow the 
instructions for submitting comments on the Agency Web site.
     Email: [email protected]. Include RIN 0906-AA73 
in the subject line of the message.
     Fax: (301) 594-6095.
     Mail: James Bowman, M.D., Medical Director, Division of 
Transplantation, Healthcare Systems Bureau, Health Resources and 
Services Administration, 5600 Fishers Lane, Room 12C-06, Rockville, 
Maryland 20857.
     Hand Delivery/Courier: James Bowman, M.D., Medical 
Director, Division of Transplantation, Healthcare Systems Bureau, 
Health Resources and Services Administration, 5600 Fishers Lane, Room 
12C-06, Rockville, Maryland 20857.
    Instructions: All submissions received must include the agency name 
and Regulatory Information Number (RIN) for this rulemaking. All 
comments received will be posted without change to http://www.hrsa.gov/
, including any personal information provided. For detailed 
instructions on submitting comments and additional information on the 
rulemaking process, see the ``Public Participation'' heading of the 
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to the Division of Transplantation, Healthcare 
Systems Bureau, Health Resources and Services Administration, 5600 
Fishers Lane, Room 12C-06, Rockville, Maryland 20857 weekdays (Federal 
holidays excepted) between the hours of 8:30 a.m. and 5 p.m. To 
schedule an appointment to view public comments, phone (301) 443-7757.

FOR FURTHER INFORMATION CONTACT: James Bowman, M.D., at the above 
address; telephone number (301) 443-4861.

SUPPLEMENTARY INFORMATION: The transplant community has performed 
transplants of hands and various body parts using the term composite 
tissue allograft; however, for the purposes of rulemaking, the Health 
Resources and Services Administration (HRSA) has defined a subset of 
such body parts as vascularized composite allografts (VCA), which share 
certain characteristics.
    Based upon a review of VCA, the Secretary believes that VCA should 
now be included within the definition of organs covered by the rules 
governing the operation of the Organ Procurement and Transplantation 
Network (OPTN) (hereinafter the OPTN final rule) (42 CFR part 121). 
This notice sets forth the history of VCA transplants, the factors that 
have persuaded the Department of the advisability of including VCA 
within the authority of the regulations governing the operation of the 
OPTN, the Secretary's oversight of VCA, and the anticipated 
consequences of this proposal. The notice also discusses the 
Department's proposal to include VCA within the definition of human 
organs covered by section 301 of the National Organ Transplant Act of 
1984, as amended (hereinafter section 301 of NOTA).

Public Participation

    Through this notice, the Secretary seeks comments from the public 
on the proposals made. Additional information on the submission of 
comments and/or the rulemaking process can be obtained from the 
Director, Division of Policy Review and Coordination, Health Resources 
and Services Administration, 5600 Fishers Lane, Room 14A-11, Rockville, 
Maryland 20857.

Background

    VCA transplantation comprises transplants of a variety of body 
parts (all of which contain similar characteristics, described later) 
that are not currently regulated under the OPTN final rule. Perhaps the 
two most notable types to date have been hand and face transplants. The 
first successful hand transplant in the United States was performed in 
1999 and the first face transplant in the U.S. was performed in 2008. 
Worldwide, there have been over three dozen limb transplants, at least 
a dozen transplants of portions of the face, and a small number of 
transplants of other such anatomical parts (e.g., abdominal wall, 
vascularized skeletal muscle, and digits). Accurate data about the 
actual number of such transplants have been difficult to obtain because 
there is no requirement for reporting these procedures in the U.S. Most 
of the available information has been obtained from published news 
accounts in the popular press and anecdotal reports in the medical 
literature.
    Although the body parts involved vary significantly, among their 
shared characteristics is the fact that they are susceptible to 
ischemia (damage or death from lack of blood flow) and that they need 
revascularization, done through a surgical reconnection of blood 
vessels to accomplish the transplant, as opposed to secondary ingrowth 
of vessels. In viable vascularized transplants, immunosuppression is 
necessary to prevent or treat rejection. This immunosuppression has 
risks, which have been justified in patients needing organs as 
presently defined in the OPTN final rule because of their lifesaving 
potential. In the past, the risks of immunosuppression have inhibited 
transplantation of VCA because the risks associated with the prolonged 
use of immunosuppressive drugs were thought to exceed the expected 
benefits of the transplants. However, the powerful impact these 
transplants can have to improve the quality of life for individuals 
with grievous disabilities has become increasingly apparent. 
Immunosuppressive management for these transplants has also improved so 
that risks associated with immunosuppression, such as cancer, 
infection, or other morbidities in recipients, are lessened 
considerably. (F Schuind, Hand transplantation and vascularized 
composite tissue allografts in orthopaedics and traumatology, 
Orthopaedics & Traumatology: Surgery & Research (2010) 96, 283-290, and 
Armed Forces Institute of Regenerative Medicine Annual Report, 2009, pp 
II-1 and II-62 and II-63). In recent years, the

[[Page 78217]]

Departments of Defense and Veterans Affairs have initiated substantial 
funding of clinical research programs for limb and face transplantation 
anticipating the reconstruction needs of wounded service members 
returning from the conflicts in Iraq and Afghanistan. More than 1,000 
military men and women have lost an arm or leg in these conflicts and 
20 percent have lost two or more limbs. As of mid-summer 2010, it was 
estimated that as many as 200 wounded troops might be eligible for face 
transplantation and about 50 for hand/forearm transplants. Most of the 
funding for limb and face transplantation research in the U.S. 
currently comes from the Departments of Defense and Veterans Affairs 
(Armed Forces Institute of Regenerative Medicine Annual Report, 2009, 
pp I-1 and I-2). For these reasons, it is likely that the numbers of 
VCA transplanted will increase in the future.
    Human cells or tissue intended for implantation, transplantation, 
infusion, or transfer into a human recipient are regulated as a human 
cells, tissues, and cellular and tissue-based products or HCT/Ps. The 
Food and Drug Administration (FDA) regulates HCT/Ps under 21 CFR parts 
1270 and 1271. Examples of such tissues are bone, skin, corneas, 
ligaments, tendons, dura mater, heart valves, hematopoietic stem/
progenitor cells derived from peripheral and cord blood, oocytes, and 
semen. Face and hand allografts, and other body parts meeting the 
proposed definition of VCA in this notice are currently not explicitly 
excluded from the definition of HCT/Ps under FDA regulations and are 
therefore subject to FDA oversight. The FDA has no statutory or 
regulatory authority to mandate VCA allocation policies, direct 
coordination of procurement efforts, require consistent application of 
recovery and logistics processes, or establish mandatory outcomes 
reporting and provide oversight of VCA transplant programs. FDA does 
not regulate the transplantation of vascularized human organ 
transplants such as kidney, liver, heart, lung, or pancreas. The Health 
Resources Services Administration oversees the transplantation of 
vascularized human organs.
    Given the anticipated increase in VCA transplants, HRSA published a 
Request for Information (RFI) on March 3, 2008, in the Federal Register 
for the purpose of soliciting feedback from stakeholders and the public 
as to whether VCA should be included within the definition of organs 
covered by the OPTN final rule and/or added to the definition of human 
organs covered by section 301 of NOTA. (73 FR 11420.) HRSA also sought 
feedback on the optimal way to define VCA if either definitional change 
was pursued.
    Through the RFI, HRSA invited the public to attend a meeting on 
April 4, 2008 to discuss the issues described above. The meeting was 
well attended and provided a venue for discussion on VCA issues. 
Participants were instructed to provide written comments and the 
deadline for these comments to be received by HRSA was extended to July 
2, 2008.
    In response to its RFI, HRSA received 11 written comments about 
whether VCA should be included within the definition of organs covered 
by the OPTN final rule.
    Eight of the written comments received supported including VCA 
within the definition of organs covered under the OPTN final rule. Many 
of these comments included similar supporting statements for OPTN 
oversight. The commenters agreed that the use of the existing solid 
organ transplant infrastructure would ensure rapid and equitable 
placement of VCA; allow allocation of VCA over a wide geographic area; 
facilitate identification of appropriate VCA donor and recipient pairs; 
provide assurance that all VCA programs are following similar rules, 
ensuring uniform and appropriate clinical and ethical standards on both 
the donation and transplantation side; facilitate the development of 
expertise and a body of knowledge that would be a valuable resource to 
address questions from the government or the public, and in the 
development of future policy and procedures in the field of VCA 
transplantation; enhance public transparency, increasing public 
acceptance of donation of VCA; and facilitate the protection of public 
health and safety in the context of VCA transplantation. Commenters 
also stated that the structure and goals of the OPTN are well aligned 
with the types of clinical and ethical concerns raised by VCA 
transplantation such as contingency treatment plan for complete face 
graft loss and fear of loss of facial identity due to transfer of donor 
facial characteristics (AJ Alexander et al, Arguing the Ethics of 
Facial Transplantation, Arch Facial Plast Surg. 2010;12(1):60-63) and 
with the types of entities that would be carrying out these activities, 
e.g., organ procurement organizations (OPOs) and transplant centers.
    Of the three remaining comments, two supported partial inclusion of 
VCA within the OPTN final rule's definition of organs and the third 
comment did not support having VCA included within the OPTN final 
rule's definition of organs. Of the two comments advocating partial 
inclusion of VCA under the OPTN final rule's definition of organs, one 
stated that VCA should be classified as either ``life extending'' or 
``not life extending.'' Life extending VCA were described as those 
involving: (a) Vascularized tissue, such as the use of abdominal wall 
transplanted to close a ruptured wound in a small bowel transplant 
recipient; and (b) non-vascularized tissue, such as a heart valve. Not 
life extending VCA were described as those involving: (c) vascularized 
tissue, such as a hand transplant; and (d) non-vascularized tissue, 
such as an anterior cruci, bone, or nerve grafts. The commenter 
supported including ``life extending'' VCA (a and b in the above 
examples) under the definition of organs under the OPTN final rule. 
According to this commenter, all life-saving VCA should follow the same 
rigorous testing and screening of donors and the procurement that is 
currently conducted by the OPTN contractor for organs currently covered 
under the OPTN final rule. However, the responder strongly opposed 
regulating ``not life extending'' VCA (c and d in the above examples), 
which are not conventional organ grafts, under the OPTN final rule. The 
responder suggested that although the OPTN should regulate control of 
distribution of the grafts, these two ``not life extending'' types (c 
and d) should be subject to less oversight. The commenter recommended 
new oversight legislation that would not hamper the innovation and 
utilization of these novel types of VCA. The Secretary wishes to make 
clear that certain of the body parts discussed by this commenter (e.g., 
non-vascularized tissues, such as heart valves and anterior cruci, 
bone, or nerve grafts, regardless of whether they would be considered 
life-saving or life-enhancing) are regulated by the Food and Drug 
Administration (FDA) as HCT/Ps. (21 CFR part 1271).
    The second comment supported limited oversight of VCA by the OPTN 
at this time. The commenter supported OPTN oversight with respect to 
designation of VCA transplant programs, data submission regarding 
transplant procedures, and donor screening. However, the commenter does 
not support allocation policies for VCA at this time due to the unknown 
clinical demand and overall future of these transplants. As noted 
above, clinical demand for VCA transplantation appears to be increasing 
now that immunosuppression protocols have proven safer and support for

[[Page 78218]]

military and veterans VCA transplantation programs continues to expand. 
The issues concerning allocation, recipient safety, and outcomes 
reporting are similar for VCA and for organs currently under the OPTN's 
auspices. The VCA transplant community has clearly indicated its 
support for Federal oversight of VCA as organs through the OPTN in a 
letter of request from the Association of Organ Procurement 
Organizations to the Assistant Secretary of Health (December 9, 2010) 
and a publication of recommendations by the American Society of 
Transplant Surgeons in 2011 (Implementation of Vascularized Composite 
Allografts in the United States, American Journal of Transplantation 
(2011) 11:13-17),
    The third comment did not support including VCA within the OPTN 
final rule's definition of organs. The comment stated that VCA do not 
fit as organs under HRSA oversight due to differences between solid 
organs procured for transplantation with the intent to save lives and 
VCA that are not used in life-saving applications. It also stated that 
the regulations that govern organ donation and transplantation are 
designed to maximize donation and to provide organs to as many waiting-
list recipients as possible to avoid death due to their medical 
illness. According to the commenter, VCA recipients should not be 
subject to the same risks of donor transmissible diseases as recipients 
of traditional solid organs (e.g., heart, lung, liver, and kidney). The 
commenter suggests that human-derived graft materials which enhance 
lives can be designated by Federal regulations under oversight of FDA 
as either an HCT/P, a biologic, or a medical device. However, both 
traditional organs and VCA originate from the same pool of potential 
donors and therefore subject all of these transplant recipients to 
similar risks of donor transmissible diseases. As described elsewhere, 
VCA share anatomic, clinical, allocation-logistical characteristics 
more closely related to those of traditional organs than biologics or 
medical devices. Therefore, in the Secretary's view, the appropriate 
way to distinguish those body parts that should be regulated as organs 
under the OPTN final rule and those that should not be similarly 
defined is based upon the properties of the body parts themselves 
rather than whether the intent is considered life-saving or life-
enhancing. The OPTN final rule does allow some flexibility specific to 
each organ such that the OPTN may develop distinct organ-specific 
policies tailored to the circumstances, including risk of donor 
transmissible disease by transplanting particular organs.
    The Secretary has considered comments that VCA such as hand 
transplants are not life saving and therefore are different from organs 
presently under HRSA and OPTN oversight. The Secretary does not agree 
with a direct demarcation between life-saving organ transplants and 
life-enhancing organ transplants for the purposes of defining organs 
under the OPTN final rule. The kidney has always been included in the 
list of organs governed by NOTA, the OPTN final rule, and the OPTN. 
Until additional life years provided by a kidney transplant (as opposed 
to continuing dialysis) were demonstrated, a kidney transplant was not 
understood to be life-saving. This fact did not dissuade the Congress 
from determining that kidneys should be subject to oversight under NOTA 
at its original enactment in 1984. As a result, kidney transplants are 
under the purview of the OPTN final rule and the OPTN (and subject to 
oversight by HRSA). Moreover, instead of adopting an all or nothing 
approach (life-extending versus life-enhancing), it may be better to 
understand improvements to the quality of life and increases to the 
length of life as coexisting on a spectrum of benefits. Hand and face 
transplants, and transplants of other body parts qualifying as VCA 
under the definition proposed here, may prove to be more powerful in 
improving a recipient's quality and extension of life than previously 
understood. In the Secretary's view, the appropriate way to distinguish 
between those VCA that should be regulated as organs under the OPTN 
final rule and body parts that should not be similarly defined is based 
upon the properties of the body parts themselves, rather than their 
potential impact upon the lives of their recipients.
    Upon consideration of the comments received, and for the reasons 
described below, the Secretary now proposes that transplants of VCA be 
regulated under the OPTN final rule and governed by section 301 of 
NOTA.

Adding VCA to the Definition of Organs Covered by the OPTN Final Rule

    Through this notice, the Department proposes adding VCA to the 
definition of organs included in the OPTN final rule, codified at 42 
CFR 121.2, through rulemaking. When it enacted NOTA in 1984, Congress 
included a definition of the term organ and authorized the Secretary to 
expand this definition by regulation. The Secretary has previously 
exercised this authority and expanded the statutory definition of 
organ. Currently, the OPTN final rule defines covered organs as ``a 
human kidney, liver, heart, lung, or pancreas, or intestine (including 
the esophagus, stomach, small and/or large intestine, or any portion of 
the gastrointestinal tract). Blood vessels recovered from an organ 
donor during the recovery of such organ(s) are considered part of an 
organ with which they are procured for purposes of this part if the 
vessels are intended for use in organ transplantation and labeled `For 
use in organ transplantation only.'''
    One of the major reasons NOTA was enacted and affirmed by several 
amendments was to establish an organ allocation system that functions 
equitably on a nationwide basis with provisions for outcomes reporting 
and evaluation. Prior to the enactment of NOTA, deceased donor organs 
were allocated regionally, based on relationships between transplant 
programs and donor hospitals. Congress recognized the need to allocate 
this national resource on a national and equitable basis. To ensure 
equitable access for those awaiting VCA transplantation, there is a 
need to provide for consistency in allocation processes and reliable 
outcomes reporting on a nationwide basis. Appropriate Federal oversight 
of a national allocation system can increase safety of such transplants 
and provides equitable and consistent national access to such 
transplants while also conveying to the public that donation for such 
purpose will serve an essential medical need. The FDA does not have 
statutory authority to provide oversight of VCA allocation, outcomes 
reporting, or promotion of donation. The Secretary believes that the 
rationale for a national system of organ allocation and outcomes 
reporting underlying NOTA applies to VCA.
    Once a body part is defined as an organ under the OPTN final rule, 
such body parts are excluded from the coverage of FDA regulations 
governing HCT/Ps. In addition, transplants involving body parts defined 
as organs under the OPTN final rule are subject to the requirements of 
the OPTN final rule. For example, entities performing transplants with 
covered organs must receive designation as an organ-specific designated 
transplant program (in this case, a designation as a VCA-specific 
transplant program) within an OPTN member institution. Members must 
comply with data submission requirements of the OPTN final rule and are 
subject to oversight by the OPTN contractor for compliance with OPTN 
policies, OPTN bylaws, and the OPTN

[[Page 78219]]

final rule. Members may be subject to Federal enforcement actions for 
violations of Federal regulations or enforceable policies (those 
approved by the Secretary of Health and Human Services) or for actions 
or inactions that indicate a risk to health of patients or to the 
public safety. Finally, OPTN members can be subject to OPTN sanctions 
for violating OPTN bylaws and non-enforceable OPTN policies (e.g., 
being declared a member not in good standing).
    As previously discussed and also explained in ``Statement of Need'' 
within the ``Impact of the New Rule'' section (below), the Secretary 
believes that oversight of the VCA transplants is necessary to ensure 
transplant recipient safety and to provide a consistent allocation 
process nationwide that will ensure equitable access to those waiting 
for VCA transplantation., to collect data on VCA transplant outcomes, 
and to maintain the public trust in the integrity of the VCA donation, 
recovery and transplant processes. Because of the clinical, 
procurement, logistical, allocation, and outcomes reporting 
similarities between VCA and organs currently under the OPTN's 
auspices, the Secretary believes that HRSA is the appropriate HHS 
agency to assure Federal oversight over VCA transplantation. HRSA 
oversees transplantation of vascularized human organs through the OPTN, 
which sets policies related to the procurement, transplantation, 
allocation, and outcomes reporting of human organs. The OPTN serves the 
critical role of matching donor organs to potential recipients on a 
national basis. The issues concerning allocation and recipient safety 
are similar for VCA and for organs currently under the OPTN's auspices. 
Additionally, the membership of the OPTN, which is charged with 
developing policies consistent with the OPTN final rule, includes 
professionals with expertise in the field. Therefore, the Secretary 
believes that the OPTN, with HRSA's oversight, will be able to 
effectively address issues involving the regulation of the emerging 
field of VCA transplantation.
    If VCA are included within the OPTN final rule's definition of 
organs, transplants involving VCA will be subject to the requirements 
of the OPTN final rule. For example, an entity performing VCA 
transplants would have to receive designation as a VCA-designated 
transplant program within an OPTN member institution. In addition, OPTN 
members would be required to comply with the OPTN final rule's data 
submission requirements with respect to the transplants performed. 
Thus, the OPTN would need to devise certain policies with respect to 
VCA, including allocation policies meeting the requirements set forth 
in the OPTN final rule. Finally, OPTN members would be subject to 
oversight by the OPTN contractor for compliance with OPTN policies 
extending to VCA (e.g., those concerning donor screening and 
allocation), and could be subject to enforcement actions for violations 
of such policies.
    Even so, the OPTN final rule does allow some flexibility specific 
to each organ. The OPTN sometimes fashions distinct organ-specific 
policies tailored to the circumstances of transplanting particular 
organs. For example, the training of professionals working for 
designated programs may vary by organ and OPTN policies with respect to 
disease transmission protocols and testing may diverge based on 
circumstances relating to particular organs. Likewise, the particular 
characteristics of and circumstances surrounding different types of 
organs lead to different OPTN allocation policies.
    In addition, if VCA are added as covered organs under the OPTN 
final rule as proposed here, the Secretary will continue to exercise 
oversight over proposed and final OPTN policies with respect to VCA, 
consistent with the authority of the Secretary under 42 CFR 121.4. 
Given the relatively small numbers of other VCA transplanted at this 
time, the Secretary does not expect that the OPTN would develop 
allocation policies for all VCA within a short time frame if VCA are 
added to the OPTN final rule's definition of organs. We expect that the 
OPTN will initially create policies addressing hands and faces as these 
two VCA have been the most frequently performed VCA transplant 
procedures in the U.S. and are the subject of extensive ongoing 
clinical research programs by the Departments of Defense and Veterans 
Affairs. We expect that the OPTN will wait to develop allocation 
policies for other VCA until the field has more clinically evolved. 
Given the Secretary's substantial interest in VCA policy and 
involvement in the operations of the OPTN, the Secretary will be 
notified of proposals to develop policies for other VCA as they are 
addressed in the future.
    The nature of the regulatory framework governing the operation of 
the OPTN underlies the importance of including VCA within the 
definition of organs covered by the OPTN final rule. Under the OPTN 
final rule, the OPTN must submit proposed policies for review and 
approval by the Secretary (42 CFR 121.4). Upon consideration of public 
comments on proposed policies that are considered significant, the 
Secretary will determine whether to make such proposed policies 
enforceable in accordance with section 121.10 of the OPTN final rule. 
The Secretary may direct the OPTN to develop individual policies for 
specific body components that are defined as VCA in addition to OPTN 
policies that apply to all VCA. Any transplant hospital that fails to 
comply with any policy approved as enforceable by the Secretary under 
this process may be subject to the enforcement sanctions delineated in 
section 121.10 of the OPTN final rule, including possible termination 
from the Medicare and Medicaid programs.
    The Secretary has the following additional authorities provided by 
the OPTN final rule (42 CFR 121.4(b)(2)), which she may exercise in the 
case of policies extending to VCA: The Secretary may require the OPTN 
Board of Directors to provide to the Secretary, at least 60 days prior 
to their proposed implementation, proposed policies on matters that the 
Secretary directs. The Secretary will refer significant proposed 
policies to the Advisory Committee on Organ Transplantation (ACOT) 
established under 42 CFR 121.12, and publish them in the Federal 
Register for public comment. This is in addition to the public comment 
process that is engaged in by the OPTN.
    The Secretary also may seek the advice of the ACOT on other 
proposed policies and publish them in the Federal Register for public 
comment.
    The Secretary will determine whether proposed policies are 
consistent with NOTA and the OPTN final rule, taking into account the 
views of the ACOT and public comments. Based on this review, the 
Secretary may provide comments to the OPTN.
    If the Secretary concludes that a proposed policy is inconsistent 
with NOTA or the OPTN final rule, the Secretary may direct the OPTN to 
revise the proposed policy consistent with the Secretary's direction. 
If the OPTN does not revise the proposed policy in a timely manner, or 
if the Secretary concludes that the proposed revision is inconsistent 
with NOTA or the OPTN final rule, the Secretary may take such other 
action as the Secretary determines appropriate, but only after 
additional consultation with the ACOT on the proposed action.
    Also, the Secretary has the authority under the OPTN Final Rule (42 
CFR 121.4(a)(6)) to require the OPTN to develop policies on such 
matters as the Secretary directs.

[[Page 78220]]

    The Secretary is legally obliged, as part of her responsibilities 
in administering the Medicare and Medicaid programs, to require 
hospitals that transplant organs to comply with the rules and 
requirements of the OPTN as a condition of their participation in 
Medicare and Medicaid. (42 U.S.C. 1320b-8(a)(1)(B).) Because VCA are 
not included within the OPTN final rule's definition of organs, the 
Secretary could not currently make any VCA allocation policy 
enforceable. If VCA are added as covered organs under the OPTN final 
rule as proposed here, the Secretary could take appropriate enforcement 
actions against an OPO or transplant hospital for failing to comply 
with the OPTN's VCA retrieval and allocation policy, if such a policy 
has been approved as enforceable by the Secretary under the process 
outlined above. If VCA are defined as organs under the OPTN final rule, 
then this will ensure that VCA organ allocation, whether pertaining to 
isolated VCA transplants or combined/multi-organ transplants, is 
consistent with OPTN final rule's goals, including that of an equitable 
national system for organ allocation, to be consistent with NOTA.
    Even if OPTN policies pertaining to VCA transplantation do not 
become enforceable, all institutions performing VCA transplantation 
would be required to comply with the provisions of the OPTN final rule 
(including the requirement that such institutions become members of the 
OPTN). Further, such institutions could be subject to sanctions by the 
OPTN for failure to comply with allocation and other OPTN policies. For 
example, a member may be named a member not in good standing by the 
OPTN for failing to comply with such a policy.
    As the field of VCA transplantation evolves, it will become more 
critical that VCA organ allocation keeps pace with advances in the 
field; that the field be subject to appropriate Federal oversight; that 
policy developments include performance indicators to assess whether 
the goals of an equitable transplant system are being achieved; that 
the Secretary have the authority to make those policies enforceable; 
and that patients and physicians have timely access to accurate data 
that will assist them in making decisions regarding VCA 
transplantation. Upon consideration of the foregoing factors, and to 
achieve the most equitable and medically effective use of donated 
organs, the Secretary proposes that VCA should explicitly be added to 
the definition of organs covered by the OPTN final rule. The Secretary 
seeks comments on this proposal.

Defining Vascularized Composite Allografts

    At the time of the RFI, and to assist the Secretary in adding VCA 
to the definition of organs covered by the OPTN final rule and/or to 
the definition of human organs governed by section 301 of NOTA, HRSA 
sought feedback from stakeholders and from the public as to how such 
allografts should be defined. HRSA identified two potential approaches: 
(1) A broad regulatory definition describing the common features of VCA 
without listing covered body parts; or (2) a definition listing body 
parts that would qualify as VCA.
    The Secretary has elected to propose the first approach, a broad 
regulatory definition that describes the features of the allografts 
without listing particular body parts. Under this approach, the 
definition would extend to transplants of particular body parts that 
are not known to have been performed clinically to date, or even to 
body parts whose transplantation has not yet been envisioned. The 
Secretary is proposing which elements should be included in the 
definition of VCA to be sufficiently broad to cover the universe of 
intended body parts, but narrow enough to put the public on notice as 
to which parts meet the regulatory definitions of organs.
    The Secretary proposes that for a body part to be defined as a VCA, 
it must have all the following characteristics: a body part (1) That is 
vascularized and requires blood flow by surgical connection of blood 
vessels to function after transplantation; (2) containing multiple 
tissue types; (3) recovered from a human donor as an anatomical/
structural unit; (4) transplanted into a human recipient as an 
anatomical/structural unit; (5) minimally manipulated, (processing that 
does not alter the original relevant characteristics of the organ 
relating to the organ's utility for reconstruction, repair, or 
replacement--examples of minimal manipulation include cutting, 
grinding, and shaping of a VCA); (6) for homologous use, (the 
replacement or supplementation of a recipient's organ with an organ 
that performs the same basic function or functions in the recipient as 
in the donor), (e.g., a hand from the donor is to be used as a hand in 
the recipient); (7) not combined with another article such as a device; 
(8) susceptible to ischemia and, therefore, only stored temporarily 
(e.g., cold storage in preservation medium and intended for 
implantation into a recipient within hours of the recovery) and not 
cryopreserved; and (9) susceptible to allograft rejection, requiring 
immunosuppression that may increase infectious disease risk to the 
recipient. This proposed definition is intended to explain to the 
public which body parts would be covered presently, while allowing 
other body parts that are transplanted to be covered as the field of 
VCA transplantation advances. A non-exclusive list of body parts that 
would meet the proposed definition for VCA here would include faces, 
hands, fingers, toes, larynges, and abdominal walls. Periodically, HRSA 
may publish an updated list of VCA in the Federal Register. In 
addition, through this definition, the Secretary intends to distinguish 
those body parts she proposes to define as organs under the OPTN final 
rule from other body parts that are regulated as HCT/Ps under FDA's 
regulatory authority.
    Under a second alternative, the Secretary could have proposed a 
definition that lists specific transplantable body parts to be added to 
the definition of organs (e.g., face, hand, etc.). The Secretary finds 
this unnecessary since the general set of nine characteristics provide 
clear identification of such body parts. Moreover, definition by an 
explicit list would likely exclude certain body parts for which 
transplantation might be possible, but not done to date (either in the 
United States or internationally). The Secretary is proposing the more 
descriptive definition to avoid the need of amending the regulatory 
definition to extend its reach to new types of transplantation that 
emerge in the future.
    HRSA received no negative feedback in response to its request for 
information on adopting this first approach or on the criteria 
discussed in the request for information (other than the comment 
distinguishing between those grafts that are lifesaving and those that 
are life enhancing). Most of the commenters supporting the inclusion of 
VCA in the definition of organs covered by the OPTN final rule would 
defer to the physicians and surgeons involved to determine the optimal 
way to define VCA. Given that Congress authorized the Department to 
modify the definition of covered organs through rulemaking, it would 
not be permissible to allow transplant surgeons and physicians (or 
others participating in the OPTN), on their own, to define VCA for the 
purposes of the final rule. However, the Secretary seeks feedback from 
the transplant community on the definition of VCA proposed here.
    Additionally, body parts allocated as VCA are intended to be used 
``intact'' as a VCA until the transplant center receiving the VCA 
determines that a

[[Page 78221]]

portion of the VCA is not needed for transplantation of the remainder 
of the VCA. If portions of a VCA are not used in connection with the 
same transplant (for example, left over bone or tendons from a limb 
allocated as a VCA), such body parts cannot be used for other purposes 
including transplantation in a different anatomical location in the 
recipient who received the VCA or in a different recipient. Disposition 
of such remnants would be subject to OPTN policies.
    Because the Secretary is proposing a definition that does not 
identify specific VCA by name, the Secretary proposes amending 42 CFR 
121.4(e) to make clear that the OPTN must identify the specific body 
parts covered by any OPTN policy specific to VCA. The purpose of this 
proposal is to ensure that all OPTN members and stakeholders understand 
the body parts covered by OPTN policies specific to VCA. Under this 
proposal, any OPTN policy that applies broadly to organs would apply to 
all body parts meeting the proposed definition for VCA unless otherwise 
provided for.
    State registries for organ and tissue donors generally provide the 
option to select organs, tissues, both, or neither. In the future we 
anticipate that states will likely further distinguish VCAs and will 
continue to permit individuals to select what they wish to donate. The 
potential impact of including VCA in the definition of organs on organ 
donation efforts, including the number of deceased donor organs that 
may become available, has not been explored. Therefore, the Secretary 
is seeking public comment on what impact this proposed expanded 
definition of organs may have on efforts to increase participation in 
deceased organ donor registries, signing organ donor cards, and general 
willingness of individuals to agree to be deceased organ donors.

Including VCA Within the Definition of Human Organs Covered by Section 
301 of NOTA

    The Secretary further proposes including VCA within the definition 
of human organs, as covered by section 301 of NOTA, which prohibits the 
purchase or sale of human organs for human transplantation. This 
criminal prohibition provides in part that ``[i]t shall be unlawful for 
any person to knowingly acquire, receive, or otherwise transfer any 
human organ for valuable consideration for use in human transplantation 
if the transfer affects interstate commerce. The preceding sentence 
does not apply with respect to human organ paired donation.'' (42 
U.S.C. 274e(a).) Section 301 of NOTA defines the term ``human organ'' 
to mean ``the human (including fetal) kidney, liver, heart, lung, 
pancreas, bone marrow, cornea, eye, bone, and skin or any subpart 
thereof and any other human organ (or any subpart thereof, including 
that derived from a fetus) specified by the Secretary of Health and 
Human Services by regulation.'' (42 U.S.C. 274e(c)(1).)
    As set forth by statute, Congress authorized the Secretary to add 
additional organs to the definition of human organ covered by section 
301 through rulemaking to include the transplantation of additional 
human organs within section 301's prohibition. The Secretary has 
previously exercised this authority. Adding VCA to this definition of 
human organs will subject persons violating its terms to VCA to 
criminal penalties.
    Through this notice, the Secretary proposes to add VCA to the list 
of human organs covered by section 301 of NOTA. The Secretary proposes 
modifying 42 CFR 121.13, which includes the definition of human organs 
covered by section 301 of NOTA, to include VCA (as defined in the 
proposed amendment to section 121.2 of the OPTN final rule). Subparts 
are being added to this definition to conform with Public Law 100-607, 
which added subparts of covered human organs to the statutory 
definition of human organs governed by section 301 of NOTA.

Economic and Regulatory Impact

    Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, when rulemaking is 
necessary, to select regulatory approaches that provide the greatest 
net benefits (including potential economic, environmental, public 
health, safety, distributive and equity effects). In addition, under 
the Regulatory Flexibility Act, if a rule has a significant economic 
effect on a substantial number of small entities the Secretary must 
specifically consider the economic effect of a rule on small entities 
and analyze regulatory options that could lessen the impact of the 
rule.
    Executive Order 12866 requires that all regulations reflect 
consideration of alternatives, costs, benefits, incentives, equity, and 
available information. Regulations must meet certain standards, such as 
avoiding an unnecessary burden. Regulations that are significant 
because of cost, adverse effects on the economy, inconsistency with 
other agency actions, effects on the budget, or novel legal or policy 
issues, require special analysis.
    The Secretary has determined that minimal resources are required to 
implement the requirements in this rule because organizations involved 
(e.g., OPOs and transplant hospitals) already implement related 
requirements for other organs in the OPTN rule (42 CFR 121.2). 
Therefore, in accordance with the Regulatory Flexibility Act of 1980 
(RFA), and the Small Business Regulatory Enforcement Act of 1996, which 
amended the RFA, the Secretary certifies that this rule will not have a 
significant impact on a substantial number of small entities.
    The Secretary also has determined that this proposed rule does not 
meet the criteria for a major rule as defined by Executive Order 12866 
and would have no major effect on the economy or Federal expenditures. 
We have determined that the proposed rule is not a major rule within 
the meaning of the statute providing for Congressional Review of Agency 
Rulemaking, 5 U.S.C. 801. Similarly, it will not have effects on State, 
local, and tribal governments or on the private sector such as to 
require consultation under the Unfunded Mandates Reform Act of 1995.
    The provisions of this rule will not affect the following elements 
of family well-being: Family safety, family stability, marital 
commitment; parental rights in the education, nurture, and supervision 
of their children; family functioning, disposable income, or poverty; 
or the behavior and personal responsibility of youth, as determined 
under section 654(c) of the Treasury and General Government 
Appropriations Act of 1999.
    As stated above, this proposed rule would modify the regulations 
governing the OPTN and section 301 of NOTA based on legal authority.

Impact of the New Rule

Statement of Need

    The field of VCA transplantation has advanced from the first hand 
transplant in the U.S. in 1999 to the point that there are now more 
than a dozen VCA transplant centers extending from coast to coast 
involving hand, face, abdominal wall, larynx, and possibly other body 
parts. The Departments of Defense and Veterans Affairs have invested 
hundreds of millions of dollars in clinical VCA transplantation 
research programs for the benefit of wounded warriors returning from 
the Iraq and Afghanistan conflicts with extensive debilitating injuries 
of the face and multiple extremities. Although the current activity 
level is less than a dozen transplants a year in the U.S., the VCA 
transplant community has begun to encounter the expansion problems 
faced

[[Page 78222]]

in the early days of organ transplantation with ensuring equitable 
access for patients to VCA, uniform allocation policies across the 
U.S., coordination of procurement efforts, consistent application of 
recovery and logistics processes, and monitoring patient safety with 
appropriate outcomes reporting and oversight of transplant programs.
    VCA transplantation consists of surgical transplants of a variety 
of body parts that currently do not fall within the current regulatory 
definition of ``organ'' covered by the rules governing the operation of 
the OPTN. Face and hand allografts, and other body parts meeting the 
definition of VCA in this notice, currently are subject to FDA 
oversight under 21 CFR parts 1270 and 1271. VCA, like organs, differ 
from tissues in that they must be transplanted within hours (not months 
or years), recipients require immunosuppression drugs to prevent or 
treat rejection, and the allocation process requires specific genetic 
and clinical matching between donor and recipient.
    The FDA has no statutory or regulatory authority to mandate 
allocation policies, direct coordination of procurement efforts, 
require consistent application of recovery and logistics processes, or 
establish mandatory outcomes reporting and provide oversight of VCA 
transplant programs. In short, the FDA's authority for regulation of 
tissues like VCA stops at the hospital door. Only the OPTN, under HRSA 
oversight, can provide reliable consistent and mandatory mechanisms and 
infrastructure to address these problems facing the VCA transplant 
community. Recognizing the need for such efforts to continue to advance 
the field of VCA transplantation, the VCA transplant community 
specifically requested the Secretary of the Department of Health and 
Human Services to provide the necessary regulatory change to define 
those body parts meeting the definition of VCA in this notice as 
``organs'' under the OPTN Final Rule so that VCA transplantation can 
continue to progress in an appropriate manner that will best serve the 
patients in need of such allografts.
    This proposed rule would have the effect of including VCA within 
the ambit of the regulations governing the operation of the OPTN, and 
would include transplanted human VCA within the prohibition set forth 
at section 301 of NOTA. If implemented, the proposals set forth in this 
rule would authorize the Secretary to take enforcement actions against 
entities violating OPTN policies pertaining to the transplantation of 
VCA once such policies are approved as enforceable by the Secretary. 
Even if the Secretary does not approve such policies as enforceable, 
OPTN members will be subject to enforcement actions by the OPTN for 
violations of OPTN policies extending to VCA. If this rule is 
promulgated, OPTN members will be required to comply with requirements 
set forth in the OPTN final rule, including those pertaining to data 
submission, as applied to VCA. Finally, if this proposal is 
implemented, individuals violating section 301 of NOTA with respect to 
VCA transplants would be subject to criminal penalties.
    If this rule takes effect, transplant centers that perform VCA 
transplantation would be required to take the necessary steps to ensure 
that VCA transplant programs are in compliance with any policies 
enacted by the OPTN specific to designated VCA allografts (e.g. hand, 
face). Such policies typically specify the clinical submission 
requirements for candidate registration on the waiting list, clinical 
information of the transplant procedure, follow up reporting on graft 
and patient outcomes, and reporting of potential donor disease 
transmission events.

Paperwork Reduction Act of 1995

    The amendments proposed in this notice of proposed rulemaking 
contain information collection activities that are very similar to, and 
based on the data collection requirements in, the OPTN final rule 
approved by the Office of Management and Budget (OMB No. 0915-0157 and 
OMB No. 0915-0184). Membership in the OPTN is determined by submission 
of application materials to the OPTN demonstrating that the applicant 
meets all required criteria for membership and will agree to comply 
with all applicable provisions of the National Organ Transplant Act, as 
amended, 42 U.S.C. 273 et seq. Section 1138 of the Social Security Act, 
as amended, 42 U.S.C. 1320b-8 requires that hospitals in which 
transplants are performed be members of, and abide by, the rules and 
requirements (as approved by the Secretary of the HHS) of the OPTN as a 
condition of participation in Medicare and Medicaid for the hospital. 
Section 1138 contains a similar provision for the organ procurement 
organizations (OPOs) and makes membership in the OPTN and compliance 
with its operating rules and requirements (as approved by the Secretary 
of the HHS), including those relating to data collection, mandatory for 
all transplant programs and OPOs. The information is used predominantly 
to match donor organs with recipients, to monitor compliance of member 
organizations with OPTN policies and requirements to guide organ 
allocation policy development, and to report periodically on the 
clinical and scientific status of organ donation and transplantation in 
this country.
    The currently-approved data collection includes worksheets and 
burden for organs and describes respondents as non-profit institutions 
and small organizations, which would be the same for this proposed 
rule. The title, description, and respondent description of all 
information collections relating to VCA are shown below with similar 
estimates of annual reporting and record keeping burden as with other 
organs previously approved in the OPTN final rule.
    Currently there are approximately 10 hand, 2 face, and 1 abdominal 
wall transplant programs in the U.S., although only 7 have actually 
performed a clinical transplant operation to date. Since the current 
rate of VCA transplants is less than 10 a year (hand) and less than 1 a 
year (face and abdominal wall), for reporting burden calculations 
(below) we have projected a total of 20 VCA transplant programs each 
registering 2 candidates a year to the waiting list and each program 
performing 1 transplant procedure a year. The data burden calculation 
in the table below assumes that data associated with entering deceased 
donor information is already accounted in the current OMB approved data 
collection forms. Specifically, it is reasonable to assume that any 
donor that would be considered as a VCA donor is also considered to be 
a donor for other organs covered by this rule. The hourly rate used for 
calculation of total burden cost to respondents is the average hourly 
wage for a transplant data coordinator ($26.00). This rate reflects the 
median annual salary and benefits for a Data Control Clerk II 
(www.salary.com) The total annual respondent burden hours (202) 
represents 10.1 hours ($262.60) per respondent.
    Title: Organ Procurement and Transplantation Network.
    Description: Information will be collected from transplant 
hospitals, organ procurement organizations, and histocompatibility 
laboratories predominantly for the purpose of matching donor VCA with 
potential recipients, monitoring compliance of member organizations 
with system rules, conducting statistical analyses, and developing 
policies relating to organ procurement and transplantation.
    The practical utility of the data collection is further enhanced by

[[Page 78223]]

requirements that the OPTN must report a variety of data to the 
Secretary, including data on performance by organ and status category, 
including program-specific data, OPO specific data, data by program 
size, and data aggregated by organ procurement area, OPTN region, the 
nation as a whole, and other geographic areas (42 CFR 121.8(c)(3)). The 
OPTN must also transmit proposed allocation policies and performance 
indicators which will be used to assess the likely effects of policy 
changes and to ensure that the proposed policies are consistent with 
the OPTN final rule.
    The OPTN and Scientific Registry must make available to the public 
timely and accurate information concerning the performance of 
transplant programs, and must respond to requests from the public for 
data needed for bona fide research or analysis purposes or to assess 
the performance of the OPTN or Scientific Registry, to assess 
individual transplant programs, or for other purposes (42 CFR 
121.11(b)(1)(C)).
    The OPTN must provide to each member OPO and transplant hospital 
the plans and procedures for reviewing applications and for monitoring 
compliance with these rules and OPTN policies. The OPTN must also 
report to the Secretary on OPOs and transplant hospitals that may not 
be in compliance with these rules or OPTN policies, and on their 
progress toward compliance.
    The OPTN and Scientific Registry are required to maintain and 
manage the information on candidates, donors and recipients.
    Description of Respondents: Non-profit institutions and small 
organizations. The estimated annual reporting burden is as follows:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                           Total burden
              Section                               Form                     Number of     Responses per       Total      Average  hours   hours/  cost
                                                                            respondents     respondent       responses     per  response        ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
121.6(c)..........................  Establishing Criteria for VCA                     20               1              20             0.5              10
                                     Acceptance.                                                                                                 $260.00
121.7(b)(4).......................  Reasons for Refusal.................              20              50            1000             0.1             100
                                                                                                                                               $2,600.00
121.9(b)..........................  Designated Transplant Program                     20               1              20             2.0              40
                                     Requirements.                                                                                             $1,040.00
121.11(b)(2)......................  Recipient Histo-compatibility.......              20               1              20             0.2               4
                                                                                                                                                 $104.00
                                    VCA Candidate Registration..........              20               2              40             0.5              20
                                                                                                                                                 $520.00
121.11(b)(2)......................  VCA Recipient Registration..........              20               1              20            0.75              15
                                                                                                                                                 $390.00
121.11(b)(2)......................  VCA Follow-Up.......................              20               1              20            0.65              13
                                                                                                                                                 $338.00
    Total.........................  ....................................              20  ..............           1,140            0.18             202
                                                                                                                                               $5,252.00
--------------------------------------------------------------------------------------------------------------------------------------------------------

List of Subjects in 42 CFR Part 121

    Health care, Hospitals, Organ transplantation, Reporting and 
recordkeeping requirements.

    Dated: August 18, 2011.
Mary Wakefield,
Administrator, Health Resources and Services Administration.
    Approved: September 7, 2011.
Kathleen Sebelius,
Secretary.
    Accordingly, 42 CFR part 121 is proposed to be amended as set forth 
below:

PART 121--ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK

    1. The authority citation for part 121 continues to read as 
follows:

    Authority:  Sections 215, 371-376 of the Public Health Service 
Act (42 U.S.C. 216, 273-274d); sections 1102, 1106, 1138 and 1871 of 
the Social Security Act (42 U.S.C. 1302, 1306, 1320b-8 and 1395hh); 
and section 301 of the National Organ Transplant Act, as amended (42 
U.S.C. 274e).


Sec.  121.2  [Amended]

    2. Amend Sec.  121.2 to revise definition for Organ and add 
definition for Vascularized composite allograft to read as follows:
* * * * *
    Organ means a human kidney, liver, heart, lung, pancreas, intestine 
(including the esophagus, stomach, small and/or large intestine, or any 
portion of the gastrointestinal tract), or vascularized composite 
allograft (defined in this section). Blood vessels recovered from an 
organ donor during the recovery of such organ(s) are considered part of 
an organ with which they are procured for purposes of this part if the 
vessels are intended for use in organ transplantation and labeled ``For 
use in organ transplantation only.''
* * * * *
    Vascularized composite allograft means a body part:
    (1) That is vascularized and requires blood flow by surgical 
connection of blood vessels to function after transplantation;
    (2) Containing multiple tissue types;
    (3) Recovered from a human donor as an anatomical/structural unit;
    (4) Transplanted into a human recipient as an anatomical/structural 
unit;
    (5) Minimally manipulated, (processing that does not alter the 
original relevant characteristics of the organ relating to the organ's 
utility for reconstruction, repair, or replacement);
    (6) For homologous use, (the replacement or supplementation of a 
recipient's organ with an organ that performs the same basic function 
or functions in the recipient as in the donor);
    (7) Not combined with another article such as a device;
    (8) Susceptible to ischemia and, therefore, only stored temporarily 
and not cryopreserved; and
    (9) Susceptible to allograft rejection, requiring immunosuppression 
that may increase infectious disease risk to the recipient.
    3. In Sec.  121.4, add paragraph (e)(3) to read as follows:


Sec.  121.4  OPTN policies: Secretarial review and appeals.

* * * * *
    (e) * * *
    (3) identify all covered body parts in any policies specific to 
vascularized composite allografts, defined in Sec.  121.2.
    4. Revise Sec.  121.13 to read as follows:

[[Page 78224]]

Sec.  121.13  Definition of Human Organ Under section 301 of the 
National Organ Transplant Act of 1984, as amended.

    Human organ, as covered by section 301 of the National Organ 
Transplant Act of 1984, as amended, means the human (including fetal) 
kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, 
skin, intestine (including the esophagus, stomach, small and/or large 
intestine, or any portion of the gastrointestinal tract), or any 
vascularized composite allograft defined in Sec.  121.2. It also means 
any subpart thereof, including that derived from a fetus.

[FR Doc. 2011-32204 Filed 12-15-11; 8:45 am]
BILLING CODE 4165-15-P